U.S. FDA approves Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR

The Manila Times

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Summary

OMLYCLO (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR (omalizumab)[1] The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases JERSEY CITY,

Source: The Manila Times

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